A Phase 3 interventional study of navenibart in Hereditary Angioedema (HAE), sponsored by Astria Therapeutics, Inc.. Enrolling by invitation at 40 sites in 18 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Astria Therapeutics, Inc. (part of BioCryst Pharmaceuticals) · Phase 3, Interventional, and Prevention
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 145 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Astria Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
First submitted before Astria Therapeutics, Inc. became part of BioCryst Pharmaceuticals.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Participants from STAR-0215-301 who met one of the following conditions:
i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 600 mg of navenibart every 3 months.
Drug: navenibart
Participants will receive 300 mg of navenibart every 3 months.
Drug: navenibart
Participants will receive 600 mg of navenibart every 6 months.
Drug: navenibart
Participants will receive 300 mg of navenibart every 3 months.
Drug: navenibart
Navenibart will be administered as a subcutaneous injection.
Also known as: STAR-0215
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Month 48
Number of time-normalized investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Number of moderate or severe investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Number of investigator-confirmed HAE attacks that require on-demand treatment
Time frame: Day 1 through Month 48
Percent reduction in monthly investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Time to first investigator-confirmed HAE attack after first dose
Time frame: Day 1 through Month 48
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate
Time frame: Day 1 through Month 48
Number of participants with no investigator-confirmed HAE attacks
Time frame: Day 1 through Month 48
Angioedema Quality of Life questionnaire total score
The Angioedema Quality of Life Questionnaire (AE-QoL) consists of 17 questions divided into four domains: functioning (4 questions), fatigue/mood (5), fears/shame (6), and food/nutrition (2). Each question is answered on a 5-point scale from "never" to "very often." Scores are calculated for each domain and then normalized to a scale from 0 to 100, where 0 represents the best possible quality of life and 100 the worst.
Time frame: Day 1 through Month 48
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Navenibart